I am basically going to start my own Ayurvedic manufacturing plant and launch several ayurvedic products. I have few questions related to regulatory part:
I want to formulate a dietary supplement with an imported ingredient, which is not currently in the ayush pharmacopeia, so how should I proceed with product registration/approval?
Also, for registration of new combination formulas, what is the procedure? Can you send me any links for procedure?
Do ingredients require approval separately or only formulations require approval?
1. If it is a Dietary supplement then there is minimum chances, you get approval as Ayurvedic Preparation. Ayurvedic preparations contains ingredients that have some clinical effects as per old Ayurvedic literatures, Ayurvedic Pharmacopeia, pharmacognosy books and other acceptable Ayurvedic references. Dietary supplements and Ayurvedic Preparations are two different things. Dietary supplements can’t claim any medicinal or treatment property where as Ayurvedic Preparations can do in some case. Now situation is unclear, imported ingredient is purely dietary supplements like vitamins or minerals etc or any herb that may have some clinical effects. If you provide any reference related to its clinical property and it is herbal form then you can proceed for approval as Ayurvedic Product.
2. If two Ayurvedic products are already using this ingredient then you can add reference of these products also with your application of your Ayurvedic Formulation with any Ayurvedic book reference if Ayush department show any objection at this ingredient.
3. Every state follow some different norms for approving new Ayurvedic products. Most of times, new approval products require three BAMS clinical trial report or as per Ayush department guidelines.
4. Approval of formulation is required but approval is granted at basis of ingredients used in it along with reference of any Ayurvedic book bearing information related to each ingredient used in it.